Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away ...

COLUMBUS, OH – Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according to LCDR ...

Weak authentication for medical devices (or a lack of it) has become a sweet spot for cyber criminals. Hackers accessed 1.2 million medical devices and exposed sensitive and protected information ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Nathan Eddy works as an independent filmmaker and journalist based in Berlin, specializing in architecture, business technology and healthcare IT. He is a graduate of Northwestern University’s Medill ...